Amgen and Kyowa Kirin capped off a decadeslong partnership in 2017, when the Big Biotech handed over $780 million to subsume their joint venture. Now, the duo is back at it in a new deal around a phase-3-ready asset worth $400 million upfront.
In exchange for that $400 million and the promise of milestones worth up to $850 million, Amgen will lead development, manufacturing and sales outside of Japan for KHK4083, an antibody Kyowa Kirin is developing for moderate to severe atopic dermatitis, or eczema. If approved, Kyowa Kirin will co-promote the drug with Amgen in the U.S. with the option to co-promote it in other markets, including some in Europe and Asia.
The treatment targets the OX40 antigen, or molecule, which is expressed on activated T cells, said Andrew McKnight, Ph.D., president and chief scientific officer of Kyowa Kirin Pharmaceutical Research.
“It is uniquely expressed on pathogenic T cells within atopic dermatitis patient … After activation, those cells express the OX40 molecules,” McKnight said.
OX40 plays a key role in the proliferation and survival of effector T cells and memory T cells. KHK4083 works in two ways: It stops the molecule from binding to its ligand, thereby blocking its function, and it depletes those activated T cells in areas of inflammatory or autoimmune disease, such as the rashes of patients with atopic dermatitis, McKnight said.
Kyowa Kirin revealed phase 2 data for the drug in February, showing that after 16 weeks of treatment, it beat placebo at reducing the area and severity of eczema. Details were slim, but the company said more patients taking KHK4083 than placebo had a 75% reduction of eczema area and severity and clear or almost clear skin as measured by the static Physician’s Global Assessment, a visual assessment of the condition. The company plans to present the full data at a medical meeting.
“That’s what really got our attention … There are about 26 million people in North America, the European Union and Japan with the disorder … And in our view, there is still a significant, residual unmet need, particularly for those patients with moderate to severe disease,” said David Reese, M.D>, executive vice president of R&D at Amgen. “We found the underlying science very compelling … and there’s a lot of evidence this pathway plays a role in various autoimmune diseases, including atopic dermatitis.”
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After Amgen shepherds the atopic dermatitis program into phase 3, development teams from both companies will discuss the drug’s potential in other diseases, McKnight said.
The partners first joined forces in 1984, when Amgen was a fledgling biotech and well before Kirin eventually merged with Kyowa Hakko. They set up a 50-50 joint venture that would develop and commercialize anemia meds Epogen and Aranesp as well as Neulasta, a treatment to reduce the chance of infection in cancer patients undergoing chemotherapy. Amgen bought out its partner of the JV in 2017 for $780 million upfront in 2017.